Pharmaceutical, Biotechnology & Diagnostic Industries

With an established record of excellence, the Edwards-Hunt Group has become a trusted name in conducting prospective human biospecimen collection studies that are fully compliant with U.S. regulatory standards.

Our comprehensive domestic network ensures prompt collection of high-quality, meticulously annotated biospecimens. These are integral to facilitating the drug/device development process, underscoring our commitment to advancing medical research.

As a reputable contract research organization, we offer a suite of services tailored to meet diverse needs:

• Principal Investigator: Our team is led by experienced investigators proficient in overseeing complex research projects.
• Regulatory Package Development: We create comprehensive regulatory packages, ensuring full compliance with all relevant guidelines.
• Study Designs: Our expertise extends to both remote and traditional study designs, allowing for flexible research methodologies.
• Biospecimen Collections: We collect a range of biospecimens including peripheral blood, urine, saliva, CSF, benign and malignant tissue, and fecal matter.
• Population Enrollment: We ensure racially and ethnically diverse population enrollment, fostering inclusivity in research studies.
• Site Identification: Our specialization lies in identifying and managing rural community centers, expanding the reach of clinical research.
• Contract & Budget Negotiation: We handle contract and budget negotiations, ensuring optimal terms for all parties involved.
• Site Management: Our services cover the full spectrum of site management, from site qualification to study closure visit.
• Staff Training: We are committed to "training up" the next generation of clinical research professionals, ensuring continuity in the field.
• Clinical Studies Management: We handle the daily management of clinical studies, ensuring smooth operation and progress.
• Monitoring Services: We provide monitoring services to ensure the integrity and quality of research data.
• Vendor Evaluation: We conduct thorough vendor evaluations, ensuring the selection of reliable partners for research initiatives.

Our dedication to maintaining high standards and delivering superior service has earned us recognition as a leading entity in the biobanking industry.

The Edwards-Hunt Group brings together a wealth of experience and insightful knowledge from the healthcare, drug/device development industries, and business methodologies to devise solutions tailored for our non-profit clients. We are uniquely equipped to comprehend and manage our clients' relationships with their constituents and business partners. Our expertise enables us to oversee programs from inception to completion, adeptly navigating partner relations to meet and surpass your business objectives.

We have a proven track record of successful collaborations with non-profit organizations, aiding them in achieving their clinical research objectives by offering a comprehensive range of services:

• Strategic Planning: The journey into the translational medicine field is intricate, necessitating an extensive array of scientific and business resources to effectively steer drug development within specific disease groups. Our team works closely with organizations to formulate and implement strategic plans spanning up to five years or less, based on the organization's unique needs.
• Program Development: Our clients require innovative programs to bolster their scientific and clinical endeavors, developed in a way that supports their fundraising activities. We conduct a thorough gap analysis of the organizations' programs, offering a structured approach to program creation, development, and implementation. Our specialization lies in managing programs from concept to execution, providing a comprehensive solution while minimizing the impact on limited internal resources. Our background empowers us to develop operational and technological programs designed to support clinical research and biobanking initiatives. We eschew a one-size-fits-all strategy, instead acknowledging the individual needs and distinctiveness of each disease group to develop programs that align with specific goals.
• Technology and Human Resource Management: In an era where resources are increasingly scarce, identifying and implementing the right technology and staff to fortify your efforts is crucial. We are equipped to analyze our clients' technology and human resource needs, providing recommendations, and managing the vendor selection process until our clients attain the efficiency and expertise necessary to support their programs.

By fusing industry expertise with business acumen, the Edwards-Hunt Group is a trusted partner in achieving your organization's objectives in the healthcare and drug/device development landscape.